Choosing Trade Enforcement Over Traditional Patent Litigation

Ventria Bioscience’s Strategic Use of the ITC to Halt Competing Chinese Imports 

When U.S.-based biotechnology company Ventria Bioscience discovered that a Chinese competitor was importing products that infringed on its patent, the company turned to the U.S. International Trade Commission (ITC) to defend its industry instead of a federal district court. In Wuhan Healthgen Biotechnology Corp. v. International Trade Commission, the Federal Circuit affirmed the ITC’s finding that Healthgen’s clinical grade cell culture media products infringed on Ventria’s patent for cell culture media made with recombinant human serum albumin (rHSA). 127 F.4th 1335, 1338 (Fed. Cir. 2025); Cell Culture Media Containing Combinations Of Proteins, U.S. Patent No. 10,618,951. The court also upheld the ITC’s determination that Ventria satisfied the “domestic industry” requirement under § 337 of the Tariff Act, confirming that the ITC’s authority can serve as a tool for U.S. facing foreign patent infringement. Healthgen, 127 F.4th at 1339. This case highlights the critical role of the ITC as a forum for American companies to protect their innovations in a global market.  

Ventria’s patent claims cell culture media containing rHSA through transgenic production via plants, specifically rice. ’951 Patent. This technology provides a more practical and ethical alternative to albumin derived through bovine or human blood and is widely used for pharmaceutical production and cell-based research. Healthgen, 127 F.4th at 1336. Healthgen imported rHSA products that Ventria claimed met limitations of its patent, but mainly their claim to cell culture media comprising less than 2% aggregated albumin. Id. The ITC found infringement based on chromatography data showing that Healthgen’s products contained about 1.1% aggregated albumin, falling within the patent’s scope. Id. at 1337. While Healthgen argued that aggregation levels could increase to non-infringing levels during shipping and storage before arrival to the U.S., the administrative judge’s initial determination cited substantial evidence to support the infringement. Id. at 1337, 1338. It relied on expert testimony and Healthgen’s own internal data to demonstrate that the albumin could not aggregate beyond the claimed limit. Id. The Federal Circuit also upheld the ITC’s finding that Ventria met the economic prong of the Tariff Act’s “domestic industry” requirement. Id. at 1339. Although Ventria’s investments in its patented Optibumin product were relatively small, the Commission found that all of its research, development, and production activities occurred within the United States. Id. The Court agreed that even modest domestic investment can satisfy the substantial investment threshold in § 337. Id. 

Traditional patent enforcement often falls short in this context. Federal district courts are often slow, costly, and limited in their jurisdiction over foreign defendants. Furthermore, monetary compensation can be difficult to collect when the infringer lacks U.S. assets, and injunctions generally do not extend to overseas production or conduct. Even then, import channels may remain open after a favorable court decision. This means that a patent victory in court may do little to prevent infringing goods from entering the U.S. market.  

The Tarriff Act of 1930 allows companies to stop infringement through customs and border control. 19 U.S.C.A. § 1337(d). The remedy for Ventria here is exclusion of Healthgen’s product, not monetary compensation or a traditional injunction. Exclusion and cease-and-desist orders prevent a foreign infringers sale or distribution within the United States. Id. These administrative remedies are often more efficient and practical than the traditional remedies offered by the court system.  

Healthgen emphasizes how patent law and trade law are intertwined when applied to a global industry. For many U.S. biotech firms, the ITC offers a form of practical enforcement where many components like reagents are produced abroad, and infringers can shift production or relabel products to evade traditional injunctions. By affirming the ITC’s findings, the Federal Circuit fortified the Commission’s role as both a trade regulator and patent enforcer. While the Tarriff Act provides an accessible mechanism for excluding infringing products, a strong enforcement posture through § 337 can also disrupt American access to essential materials, increase input costs, and complicate collaboration with foreign partners. In this case, the patented material of cell culture media with rHSA is important for research across life sciences. Aggressive exclusion orders, when applied broadly, could restrict downstream firms’ access to similar products. This begs the question: should the U.S. leverage trade enforcement to protect upstream biotech components if it risks constraining market access to important research tools? On one hand, robust enforcement is essential to preserve incentives for firms that specialize in research and development. On the other hand, trade-based remedies can function as non-tariff barriers, favoring domestic producers and limiting competition in the biotech market. Further, the court accepted that even Ventria’s relatively modest research and development investments satisfied the Tariff Act’s economic prong because they were entirely domestic. If they maintain U.S. operations, small and mid-sized companies can seek ITC relief as effectively as corporate giants could. The crux of the issue here is how the ITC’s enforcement of patent and trade laws needs to balance protecting innovation and ensuring market access to essential research tools. 

The Healthgen decision shows the importance of the ITC as both a trade regulator and a patent enforcer in a globalized biotechnology market. By affirming that even modest domestic investments can satisfy the Tariff Act’s domestic industry requirement, the Federal Circuit broadened access to § 337 protections for U.S. companies of all sizes. The case has implications regarding the conflict between safeguarding American innovation while maintaining the openness that fuels research and supply chains. As the biotechnology industry maintains a global presence, the challenge for courts and policymakers will be ensuring that the ITC’s powerful enforcement mechanisms promote genuine innovation rather than restricting access to essential scientific materials. The case serves as a reminder that effective patent protection in the modern era must navigate trade interests as well.